UG3 Project: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (AcuOA)
Sponsoring Institution: Kaiser Foundation Research Institute, Seattle WA (Performance Site)
- Kaiser Permanente Department of Research, Oakland CA (Performance Site)
- Sutter Health Research Institute, Palo Alto CA (Performance Site)
- Institute of Family Health, New York City NY (Performance Site)
- University of Washington, Seattle WA
NIH Institute Providing Oversight: National Center for Complementary and Integrative Health (NCCIH)
Program Official: Robin Boineau, MD, MA
Project Scientist: Basil Eldadah, MD, MPH (National Institute on Aging [NIA])
A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults with chronic low back pain (cLBP). Acupuncture has been found to be effective in treating cLBP in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. AcuOA is a pragmatic randomized trial designed to address this gap.
After a planning year to refine strategies to identify and recruit patients, finalize acupuncture protocols with an acupuncture advisory panel, and ensure data infrastructure and quality, the study team will conduct a three-arm trial of 828 adults ≥65 years of age with cLBP to evaluate acupuncture versus usual care. The study will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. The primary outcomes of this large trial will be back-related function at 26 weeks. These and other biopsychosocial measures will be collected at 12, 26, and 52 weeks post-randomization. The expectation is that back-related function in older adults with cLBP will be most improved among participants in the enhanced acupuncture arm, followed by the standard acupuncture arm, and least improved among those receiving only usual care.
Medicare is also interested in data on the value of acupuncture for older adults to inform coverage decisions and efficient implementation. As such, to supplement knowledge gained from the effectiveness trial, the study team will conduct a cost-effectiveness analysis of both forms of acupuncture compared with usual care as well as comprehensive qualitative evaluations to understand, describe, and explain barriers and facilitators to adoption, implementation, and sustainability of acupuncture treatment for older adults.
The large study sample will be recruited from four diverse health plans to represent the ethnic and racial composition of Medicare enrollees as well as the most common ways acupuncture is incorporated in insurance-based care for chronic pain. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP. This evidence will provide essential information for Medicare regarding coverage decisions and for individual physicians and patients deciding on a course of treatment.